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Completed

NCT Number: NCT02352441

Cognitive Rehabilitation:ACTION Training for Soldiers With Executive Dysfunction

Many Service members (SM) experience executive dysfunction associated with mild traumatic brain injury symptom complex (mTBI-sc), for which they receive cognitive rehabilitation. Cognitive rehabilitation (CR) for executive dysfunction often involves metacognitive strategy instruction (MSI) to help patients self-regulate their behavior though a goal management process - identifying a goal, anticipating performance problems, generating possible solutions, self-monitoring performance during the activity, recognizing maladaptive task strategies, stopping and then modifying real-time task behavior by choosing an alternate strategy. MSI alone often does not result in improved daily functioning because it requires conscious cognitive oversight to employ (which is difficult for people with executive dysfunction) and it presumes that simply establishing goals propels goal-directed action, when for many people, this is not so. Social psychologists report that people who set implementation intentions (if-then statements that link specific situational cues with specific goal actions) are more likely to perform goal actions than those who only set goal intentions. Implementation intentions are believed to be effective because they enable people to switch from conscious-effortful reflective action control to automatic, reflexive action control associated with selected situational cues. A team of researchers from the Courage Kenny Research Center (CKRC), Traumatic Brain Injury Center at Fort Campbell, KY (TBIC-FC), and Neurofunctional Research and Consulting has developed a brief CR intervention to teach SM with mTBI-sc to set implementation intentions called ACTION (AutomatiC iniTiation of IntentiONs) sequence training. The purpose of this pilot study to evaluate: 1) the practicality of instructional methods used to teach SM with mTBI-sc to perform the ACTION sequence and 2) the efficacy of ACTION sequence training in achieving personal goals and performance on a task that challenges executive function using a small randomized controlled trial. If the results are positive, a larger study would be conducted to determine the impact of ACTION sequence training on SM performance on military-relevant tasks and goals.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fort Campbell Intrepid Spirit

Fort Campbell North, Kentucky, 42223, United States

About this study

The primary aims of this feasibility study are as follows:

Aim 1: Finalize ACTION training curriculum; develop manuals; field test .

  • Work with implementation intentions research expert and a military consultant to develop a training task gradation schema which informs the identification and modification of existing implementation intentions training tasks so that they have military face validity.
  • Finalize the adherence support methods and other training worksheets and materials.
  • Field test training tasks and adherence support methods on small cohort of civilians with mTBI-sc from CKRC to assure feasibility.
  • Finalize ACTION sequence training manuals; assure intra-rater and inter-rater reliability for scoring quality of implementation intentions statements.

Aim 2: Evaluate ACTION sequence training instructional methods (the extent to which SM with mTBI-sc are able to learn to establish IF-THEN statements that have the potential to trigger automatic enactment of goal-actions and the extent to which SM with mTBI-sc report the training experience as satisfactory and beneficial).

  • Enroll up to 28 participants in the study (SM with mTBI-sc who are referred to MSI at TBIC-FC).
  • Evaluate whether or not participants can correctly craft implementation intentions by using a rubric to score implementation intentions developed by participants during clinic sessions and during home practice; administer participation satisfaction survey at posttest.

Aim 3: Test the efficacy of ACTION sequence training by evaluating the extent to which training 1) improves SM's with mTBI-sc ability to perform a complex test of executive function (e.g. Hotel Test) and 2) advances progress towards self-identified goals in daily life (via Canadian Occupational Performance measure [COPM] and Goal Attainment Scaling [GAS]) as compared to a control condition. Additionally, determine level of adherence to completing daily homework practice ans assigned prospective memory tasks.

  • Collect pre-post data on the Hotel Test, COPM, GAS on all participants.
  • Collect data on completion of homework assignments
  • Collect data on completion of prospective memory tasks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The sample population at the Traumatic Brain Injury Clinic- Fort Campbell (TBIC-FC) will consist of active duty army soldiers, reservists, national guardsmen, airmen, and retirees; the majority of the sample population will be active duty army soldiers. Study volunteers will be recruited from among service members assessed in the TBIC-FC and referred to the Cognitive Clinic for performance problems secondary to reported / suspected combat-related mTBI-sc.

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Exclusion criteria

Not willing to sign consent to participate.

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Treatment and study plan

Implementation Intentions(II)

Other

Implementation Intention training will include:

Demonstration and practice using examples and personal goals identified at first session. Worksheets will be provided to practice IF-THEN statements to set Implementation Intentions. Additionally, at the end of each session, the participant will be instructed to perform and event based or time based task. The objective is to see if those receiving II training are more likely to carry out the assigned task than those who do not receive II training. They will also be expected to practice II at least 5 days/week using personal goals.

Primary outcomes

  1. Change in performance of the Hotel Task

    Time frame: Baseline and end of 3 weeks

    The Hotel Task requires the participant to perform a set of 6 tasks in 10 minutes with the instruction to perform all tasks with no expectation for completing any of the tasks. This task tests the ability of the participant to shift. Measurements associated with this task include time spent on each task and number of tasks completed.

  2. Change in the Canadian Occupational Performance Measure

    Time frame: Baseline and end of 3 weeks

    Participants will provide their self-perceived performance on three everyday tasks identified and prioritized as problematic.

  3. Change in Goal Attainment Scaling

    Time frame: Baseline and end of 3 weeks

    Attainment of five goals linked to selected five everyday tasks

Secondary outcomes

  1. Performance of assigned tasks given at the end of each of the 6 II sessions

    Time frame: End of sessions 1 and 2 for each of weeks 1, 2, and 3

    Monitoring performance of the assigned event or time based task, Yes(2 points)/No(0 points)/Partial(1 point)

  2. Performance of homework

    Time frame: 4 days / week for each of the 3 weeks of study participation

    Participant will be expected to call in and report having done assignment

Sponsors and collaborators

Lead sponsor

Allina Health System

Other

Registry information

Acronym: ACTION

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 2, 2015
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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